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Breast Lymph Node Mapping

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01038908
First received: December 22, 2009
Last updated: February 12, 2013
Last verified: February 2013

December 22, 2009
February 12, 2013
June 2013
June 2014   (final data collection date for primary outcome measure)
Map arm lymphatic drainage system in the axilla [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01038908 on ClinicalTrials.gov Archive Site
Decrease the occurrence of lymphedema [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Breast Lymph Node Mapping
Axillary Reverse Mapping in Breast Cancer

The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.

This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND.

Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Breast Cancer
  • Other: Isosulfan Blue (Patent Blue Dye V)
    1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
    2. Pre-incision: SLN is identified
    3. Inject blue dye into patient's arm
    4. Complete procedure (SLNB and/or ALND)
  • Other: Isosulfan Blue (Patent Blue Dye V)
    1. Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe
    2. Pre-incision: SLN is not identified (No localization)
    3. Inject blue dye into breast (nothing in arm)

    i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND)

  • Active Comparator: 1
    Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol.
    Intervention: Other: Isosulfan Blue (Patent Blue Dye V)
  • Active Comparator: 2
    Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol.
    Intervention: Other: Isosulfan Blue (Patent Blue Dye V)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 19-100 years old
  2. Not pregnant or breastfeeding
  3. Breast cancer requiring LN evaluation for the breast
  4. Willing participation following an informed consent process

Exclusion Criteria:

  1. Patient < 19 y/o or > 100 y/o
  2. Pregnant or breastfeeding
  3. Allergy to blue dye
  4. Locally advanced axillary disease
  5. History of receiving neoadjuvant chemotherapy treatment
  6. Prior axillary surgery or radiation therapy
Both
19 Years and older
No
Contact: Sam Wiseman, MD, FRCSC, FACS 604-806-9108 smwiseman@providencehealth.bc.ca
Canada
 
NCT01038908
H09-00926
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Sam Wiseman, MD, FRCSC, FACS University of British Columbia
Study Director: Urve Kuusk, MD, FRCSC University of British Columbia
Study Director: Carolyne Dingee, MD,FRCSC University of British Columbia
Study Director: Elaine McKevitt, MD, FRCSC University of British Columbia
University of British Columbia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP